Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Study confirms cardiac surgery drug increases death rate

21.02.2008
The largest study to date of a controversial cardiac surgery drug shows it increases death rates and damages kidney function, according Duke University Medical Center researchers.

Aprotinin, a drug used to limit bleeding, was temporarily suspended from marketing in the U.S. in November 2007 after a small Canadian study was stopped because similar findings were discovered. The drug, Trasylol, is manufactured by Baylor AG.

"We're not surprised by the results,” says Dr. Andrew Shaw, an associate professor in Duke Medicine’s department of anesthesiology and the lead author of the paper which appears in the February 21 edition of the New England Journal of Medicine. “It's what we expected to find.”

The Duke study is significant because “it is more than twice the size of the next largest study of aprotinin,” says Shaw. The prospective data was collected between 1996 and 2005. “Unlike the highly selected nature of randomized trial populations, our data represent the every day cardiac bypass surgery patient population. The data were collected at a time when aprotinin was thought to be safe.”

The Duke team started analyzing its database of patients after a 2006 NEJM study reported aprotinin use may increase the risk of heart attack, stroke and serious kidney injury.

“We were looking for an association between exposure to the drug and subsequent adverse outcomes,” Shaw says. “We found an increased incidence of death in patients who received aprotinin. That higher death rate seemed to persist even when we were able to control for the differences seen between the patient groups.”

Shaw and his Duke colleagues also linked aprotinin to impaired kidney function. “Kidney function is measured by serum creatinine levels which indicate how well the blood is filtering waste products,” he says. The study found aprotinin use increased serum creatinine levels, but they did not report an increase in patients needing dialysis. Shaw believes “that’s because we probably didn’t have enough patients who needed dialysis in our study to detect a significant statistical difference, although the incidence was numerically higher.”

Of the 10,275 patients studied, 1343 patients (13.2%) received aprotinin, 6776 patients (66.8%) received aminocaproic acid (another drug used to limit bleeding) and 2029 patients (20.0%) received no therapy. All patients underwent coronary-artery bypass surgery (CABG), and 1181 of them also underwent valve surgery. Patients who received either aminocaproic acid or no therapy did not have high rates of death or poor kidney function seen in the aprotinin group.

After gaining FDA approval in 1993, aprotinin was used routinely during cardiac surgery, particularly on high-risk patients, to reduce bleeding and the need for blood transfusion. According to previously published research, patients undergoing cardiac surgery receive approximately one fifth of all the red cell transfusions in the U.S., and each unit transfused is known to increase the risk of infection.

Shaw says this study does not rule out the possibility that the increased death rate was due to high-risk, sicker patients receiving the drug. “You would expect sicker patients would be more likely to die,” he said.

“The unanswered question is, ‘are there differences between the patient groups that we were unable to detect that led to the increased death rate, or is the death rate due to exposure to the drug?’

“Our study doesn’t answer that question nor was it designed to,” he says. “But it does further raise the question of the safety of aprotinin. And, on a broader scale, it highlights the importance of post-marketing observational studies of drugs that are widely used.”

Lauren Shaftel Williams | EurekAlert!
Further information:
http://www.duke.edu

More articles from Studies and Analyses:

nachricht Self-organising system enables motile cells to form complex search pattern
07.05.2019 | Westfälische Wilhelms-Universität Münster

nachricht Mouse studies show minimally invasive route can accurately administer drugs to brain
02.05.2019 | Johns Hopkins Medicine

All articles from Studies and Analyses >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Self-repairing batteries

UTokyo engineers develop a way to create high-capacity long-life batteries

Engineers at the University of Tokyo continually pioneer new ways to improve battery technology. Professor Atsuo Yamada and his team recently developed a...

Im Focus: Quantum Cloud Computing with Self-Check

With a quantum coprocessor in the cloud, physicists from Innsbruck, Austria, open the door to the simulation of previously unsolvable problems in chemistry, materials research or high-energy physics. The research groups led by Rainer Blatt and Peter Zoller report in the journal Nature how they simulated particle physics phenomena on 20 quantum bits and how the quantum simulator self-verified the result for the first time.

Many scientists are currently working on investigating how quantum advantage can be exploited on hardware already available today. Three years ago, physicists...

Im Focus: Accelerating quantum technologies with materials processing at the atomic scale

'Quantum technologies' utilise the unique phenomena of quantum superposition and entanglement to encode and process information, with potentially profound benefits to a wide range of information technologies from communications to sensing and computing.

However a major challenge in developing these technologies is that the quantum phenomena are very fragile, and only a handful of physical systems have been...

Im Focus: A step towards probabilistic computing

Working group led by physicist Professor Ulrich Nowak at the University of Konstanz, in collaboration with a team of physicists from Johannes Gutenberg University Mainz, demonstrates how skyrmions can be used for the computer concepts of the future

When it comes to performing a calculation destined to arrive at an exact result, humans are hopelessly inferior to the computer. In other areas, humans are...

Im Focus: Recording embryonic development

Scientists develop a molecular recording tool that enables in vivo lineage tracing of embryonic cells

The beginning of new life starts with a fascinating process: A single cell gives rise to progenitor cells that eventually differentiate into the three germ...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

SEMANTiCS 2019 brings together industry leaders and data scientists in Karlsruhe

29.04.2019 | Event News

Revered mathematicians and computer scientists converge with 200 young researchers in Heidelberg!

17.04.2019 | Event News

First dust conference in the Central Asian part of the earth’s dust belt

15.04.2019 | Event News

 
Latest News

Summit charts a course to uncover the origins of genetic diseases

22.05.2019 | Life Sciences

New study finds distinct microbes living next to corals

22.05.2019 | Life Sciences

Stellar waltz with dramatic ending

22.05.2019 | Physics and Astronomy

VideoLinks
Science & Research
Overview of more VideoLinks >>>